Hobson Prior is recruiting for a Regulatory Affairs CMC Manager job based in the UK. The role is based within a significantly expanding regulatory team and it an exciting opportunity for the successful candidate to work on innovative and pioneering products at a client who is regarded as a leader in T Cell programming technologies.
Regulatory Affairs CMC Manager – UK
- Oversee the creation of CMC (Chemistry, Manufacturing and Controls) related submission documentation from the planning stages through to the review
- Identify and acknowledge any regulatory risks that may impact the strategic and operational plans and propose options to mitigate risks
- Review Health Authority CMC related regulations and ensure compliance, referring to cell and gene therapy guidelines as necessary
- Ensure timely and effective regulatory submissions to support product progression, working alongside cross-functional CMC and manufacturing team members and external providers
- Provide support to the regulatory affairs CMC director where applicable
- Excellent communication skills and the ability to work cohesively and collaboratively within a team
- Can multitask effectively, managing numerous projects and activities simultaneously
- Great attention to detail
- Bachelor’s degree in life sciences – Masters or PhD would be preferable
- Minimum 5 years’ experience in regulatory affairs with a focus on CMC
- Proven working knowledge of FDA and EU CMC regulations and guidelines
- Experience in CMC biologic drug development
- A wealth of experience of drafting CMC sections of IMPD Clinical Trial Authorisation (CTA) applications and maintenance submissions would be advantageous
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading specialist life science recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.